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Orion Pharma (UK) Limited
Oaklea Court, 22 Park Street, Newbury, Berkshire, RG14 1EA
Telephone: +44 (0)1635 520 300
Fax: +44 (0)1635 580 180
Medical Information e-mail: medicalinformation@orionpharma.com
Out of Hours Telephone: +44 (0)1635 520 300

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 11/01/2012
SPC Stalevo 75/18.75/200mg

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 11/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   31-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
A new strength of Stalevo has been introduced, so all SmPC's are updated to reflect this.
Updated on 10/09/2010 and displayed until 11/01/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   26-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 4.8, the separately compliled entacapone and levodopa/carbidopa adverse effect data has been  in to a single table.
Updated on 21/06/2010 and displayed until 10/09/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.4 (Special warnings and precautions for use) 13 paragraph amended -
-  ........    weight decrease.  ' Prolonged or persistent diarrhoea appearing during use of entacapone may be a sign of colitis. In the event of prolonged or persistent diarrhoea, the drug should be discontinued and appropriate medical therapy and investigations considered.'

In section 10 (Date of Revision of the Text) 2 June 2010 has been inserted
Updated on 19/04/2010 and displayed until 21/06/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In sections 4.4 (special warnings and precautions) and 4.8 (undesirable effects) both updated
In section 6.1 (list of excipients) Yellow iron oxide had been deleted
In section 10 Date of Revision of Text has been changed.
Updated on 23/06/2009 and displayed until 19/04/2010
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  entacapone
  levodopa
  carbidopa